NCT01586676

Brief Summary

The virtual requirement that substance abuse programs use evidence-based treatments (EBT) has prompted the development of dissemination strategies to promote EBT technology transfer. Implementation research, clinical trial training methods, and clinician training studies suggest that clinical supervision that involves direct observation, fidelity rating-based feedback, and coaching of therapeutic skills is a promising dissemination approach. However, clinical supervision delivered within substance abuse programs by on-site supervisors has never been directly tested in a randomized controlled trial to determine the impact of supervision on both clinician EBT skills and client treatment outcomes. Recent results from two NIDA CTN protocols testing the effectiveness of Motivational Interviewing (MI) have shown that community program clinicians can learn to deliver MI with fidelity when receiving MI supervision from their program supervisors after workshop training and that their implementation of MI early in treatment improves client retention and primary substance use outcomes. A MI supervision manual called MIA: STEP (Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency) was developed from these protocols and has begun to be widely distributed by NIDA in partnership with SAMHSA for community program use. The effectiveness of the MIA: STEP supervision approach is unknown. This study will directly test the effectiveness of MIA: STEP supervision on clinician MI fidelity and on client outcomes by randomly assigning 60 clinicians and 420 substance-using outpatients from 11 community programs within Connecticut to one of two conditions in which clinicians in both conditions will deliver a 1-session MI intervention to clients as the enter treatment. The conditions are: 1) workshop training plus MIA: STEP supervision, and 2) workshop training alone with supervision-as-usual practices used at each program. This project will be the first randomized trial to examine the impact of clinical supervision in an empirically based treatment on both clinician and client outcomes. Moreover, because it will provide workshop training and supervision completely within the context of community programs and utilize in-house program supervisors, it will provide a rigorous evaluation of a feasible model for disseminating EBTs such as MI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 11, 2017

Status Verified

October 1, 2015

Enrollment Period

4.7 years

First QC Date

April 25, 2012

Last Update Submit

January 10, 2017

Conditions

Keywords

supervisionmotivational interviewingsubstance abusedissemination

Outcome Measures

Primary Outcomes (1)

  • client retention

    The main outcome for the client participant trial is program retention at 4-week and 12-week followups after having received a 1-session intake. Program retention is defined as the the percent days of program attendances (days attended/# days scheduled) and percent sessions attended (sessions attended/# sessions scheduled) verified by administrative record and interview with clinical staff

    4-week and 12-week follow-up

Secondary Outcomes (1)

  • motivational interviewing adherence and competence

    baseline, post-trial and 16-weeks post-trial

Study Arms (2)

MIA: STEP

EXPERIMENTAL

Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP)

Behavioral: MIA: STEP

Supervision-as-usual

ACTIVE COMPARATOR

Supervision-as-usual consists of the typical clinical supervision services provided to clinicians by their supervisors in their community programs.

Behavioral: SAU

Interventions

SAUBEHAVIORAL

Supervision-as-usual

Supervision-as-usual
MIA: STEPBEHAVIORAL

Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP

MIA: STEP

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older who work at one of the 12 participating programs
  • willing to serve as study clinicians and learn the MI assessment intake
  • working at least 20 hours per week at the program
  • are not intending to give notice to their employer that they intend to leave the agency or are not scheduled for medical or family leave during the study period
  • willing to record clinical sessions for review by the MI expert and/or independent raters
  • willing to have supervision sessions recorded if randomized to MIA: STEP condition
  • deemed capable by program administrative leadership to manage the responsibilities of being a clinician in a randomized trial

You may not qualify if:

  • served as MI therapists in prior clinical trial studies.
  • received formal supervision in MI based on direct observation, session ratings, and related feedback and coaching.
  • trained as MI trainers through the Motivational Interviewing Network of Trainers (MINT).
  • For Clients
  • English-speaking
  • seeking non-opiate replacement outpatient treatment for any substance use problem and have used primary substance (alcohol or illicit drug) at least once in the prior 28 days
  • years of age or older
  • willing to participate in the protocol (randomization to clinicians contact for follow-up assessments, MI session recording for supervisor and independent review)
  • insufficiently medically or psychiatrically stable to participate in outpatient treatment.
  • highly unlikely to be reached for follow-up due to residential instability or imminent incarceration.
  • seeking detoxification only, opiate replacement treatment, or residential inpatient treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (5)

  • Martino S. Strategies for training counselors in evidence-based treatments. Addict Sci Clin Pract. 2010 Dec;5(2):30-9.

    PMID: 22002451BACKGROUND
  • Olmstead TA, Abraham AJ, Martino S, Roman PM. Counselor training in several evidence-based psychosocial addiction treatments in private US substance abuse treatment centers. Drug Alcohol Depend. 2012 Jan 1;120(1-3):149-54. doi: 10.1016/j.drugalcdep.2011.07.017. Epub 2011 Aug 9.

    PMID: 21831536BACKGROUND
  • Olmstead T, Carroll KM, Canning-Ball M, Martino S. Cost and cost-effectiveness of three strategies for training clinicians in motivational interviewing. Drug Alcohol Depend. 2011 Jul 1;116(1-3):195-202. doi: 10.1016/j.drugalcdep.2010.12.015. Epub 2011 Jan 31.

    PMID: 21277713BACKGROUND
  • Martino S, Ball SA, Nich C, Canning-Ball M, Rounsaville BJ, Carroll KM. Teaching community program clinicians motivational interviewing using expert and train-the-trainer strategies. Addiction. 2011 Feb;106(2):428-41. doi: 10.1111/j.1360-0443.2010.03135.x. Epub 2010 Oct 6.

    PMID: 20925684BACKGROUND
  • Martino S, Brigham GS, Higgins C, Gallon S, Freese TE, Albright LM, Hulsey EG, Krom L, Storti SA, Perl H, Nugent CD, Pintello D, Condon TP. Partnerships and pathways of dissemination: the National Institute on Drug Abuse-Substance Abuse and Mental Health Services Administration Blending Initiative in the Clinical Trials Network. J Subst Abuse Treat. 2010 Jun;38 Suppl 1(Suppl 1):S31-43. doi: 10.1016/j.jsat.2009.12.013.

    PMID: 20307793BACKGROUND

MeSH Terms

Conditions

Signs and SymptomsSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Officials

  • Steve Martino, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry (Psychology Section)

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 27, 2012

Study Start

January 1, 2009

Primary Completion

September 1, 2013

Study Completion

May 1, 2014

Last Updated

January 11, 2017

Record last verified: 2015-10

Locations